Entyvio (Intravenous)

Commonly used brand name(s)

In the U.S.

Entyvio

Available Dosage Forms:

Powder for Solution

Pharmacologic Class: Monoclonal Antibody

Uses For Entyvio

Vedolizumab injection is used to treat Crohn's disease and ulcerative colitis in patients who have not been helped by other medicines. This medicine is a monoclonal antibody that works on the immune system.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using Entyvio

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of vedolizumab injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of vedolizumab injection in the elderly.

Pregnancy

Pregnancy Category

Explanation

All Trimesters

B

Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Infection—May decrease your body's ability to fight an infection.

Proper Use of Entyvio

A doctor or other trained health professional will give you this medicine. It is given through a needle that is placed in one of your veins.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Precautions While Using Entyvio

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Vedolizumab may cause an infusion reaction while you are receiving it or right after the infusion ends. Check with your doctor or nurse right away if you have chest pain, a fever, chills, itching, hives, a rash, dizziness, fainting, lightheadedness, a headache, joint pain, difficulty with swallowing, trouble breathing, or swelling of the face, tongue, and throat.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth with this medicine.

Your body's ability to fight an infection may be reduced with this medicine. Avoid being near people who are sick and wash your hands often. Tell your doctor if you have ever had an infection that would not go away or an infection that kept coming back. Check with your doctor right away if you have a fever, chills, cough, flu-like symptoms, or unusual tiredness or weakness.

This medicine may increase your risk of getting a rare brain infection called progressive multifocal leukoencephalopathy (PML). Call your doctor right away if you have back pain, blurred vision, confusion, dizziness, drowsiness, a fever or headache, seizures, or unusual tiredness or weakness.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

While you are being treated with vedolizumab, do not have any immunizations (vaccines) without your doctor's approval. Your vaccinations need to be current before you receive vedolizumab.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Entyvio Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Body aches or pain

chills

difficulty with breathing

ear congestion

fever

headache

loss of voice

nasal congestion

runny nose

sneezing

sore throat

unusual tiredness or weakness

Less common

Back pain

chest tightness

flushing

nausea and vomiting

weakness

Rare

Cough

difficulty with swallowing

dizziness

fast heartbeat

hives, itching, or skin rash

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

tightness in the chest

Incidence not known

Abdominal or stomach pain

blurred vision

clay-colored stools

confusion

convulsions

dark urine

drowsiness

headache

loss of appetite

lower back or side pain

painful or difficult urination

unpleasant breath odor

vomiting of blood

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Difficulty with moving

muscle pain or stiffness

pain in the joints

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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